This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
10 Chedaogou Rd.,Haidian District, Beijing, China
Beijing, Beijing Municipality, China
The Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum LDL-C level after dosing SYH2053
measure the LDL-C level in blood by lab examination and evaluate the effect of SYH2053 on LDL-C Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum PCSK9 level after dosing SYH2053
measure the PCSK9 level in blood by lab examination and evaluate the effect of SYH2053 on PCSK9 Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
PK parameters (Cmax)
maximum peak observed plasma SYH2053 concentration in treated subjects
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (Tmax)
time to reach maximum peak plasma SYH2053 concentration in treated subjects
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (AUC)
area under the plasma concentration-time curve in SYH2053 treated subjects
Time frame: Pre-dose and multiple timepoints up to 4 days
PK parameters (T1/2)
the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in SYH2053 treated subjects
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Time frame: Pre-dose and multiple timepoints up to 4 days
Immunogenicity of SYH2053
Rate of formation of anti-drug antibodies to SYH2053
Time frame: Pre-dose and multiple timepoints up to 57 days
The serum TC level after dosing SYH2053
measure the TC level in blood by lab examination and evaluate the effect of SYH2053 on TC Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum TG level after dosing SYH2053
measure the TG level in blood by lab examination and evaluate the effect of SYH2053 on TG Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum HDL-C level after dosing SYH2053
measure the HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on HDL-C Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum Lp(a) level after dosing SYH2053
measure the Lp(a) level in blood by lab examination and evaluate the effect of SYH2053 on Lp(a) Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum VLDL-C level after dosing SYH2053
measure the VLDL-C level in blood by lab examination and evaluate the effect of SYH2053 on VLDL-C Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum non-HDL-C level after dosing SYH2053
measure the non-HDL-C level in blood by lab examination and evaluate the effect of SYH2053 on non-HDL-C Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum ApoA1 level after dosing SYH2053
measure the ApoA1 level in blood by lab examination and evaluate the effect of SYH2053 on ApoA1 Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum ApoB level after dosing SYH2053
measure the ApoB level in blood by lab examination and evaluate the effect of SYH2053 on ApoB Level
Time frame: Pre-dose and multiple timepoints no less than 57 days
The serum hsCRP level after dosing SYH2053
measure the hsCRP level in blood by lab examination and evaluate the effect of SYH2053 on hsCRP Level
Time frame: Pre-dose and multiple timepoints no less than 57 days